Towering stainless steel bioreactors have long since been the focal point of many biopharmaceutical manufacturing facilities. However, over the last few years this familiar landscape has changed. Single-use systems have created a real buzz in the industry, and their use is becoming rapidly more widespread. But why have single-use systems emerged as an alternative to traditional stainless steel?
We look at five advantages of using single-use systems over traditional stainless-steel technologies:
Higher Productivity
A facility’s productivity is greatly influenced by how quickly batch turn-around can be achieved. With traditional stainless-steel systems, the process is lengthened due to necessary cleaning requirements. However, when it comes to single-use systems, a new pre-assembled fluid flow path can be installed as soon as the previous batch is processed. This feature greatly reduces downtime between batches, allowing for greater production rates.
Increased Process Flexibility
When it comes to facilities that manufacture more than one product or contract manufacturing organisations, single-use technologies can prove extremely beneficial. Due to the use of disposable silicone tubing, this can easily be modified unlike stainless steel piping. Single-use technologies offer more flexibility due to the ability to change processes safely and swiftly.
Reduced Risk of Cross-Contamination
Unlike stainless steel systems, with single-use technologies, the product flow path is disposed of after the processing of each batch. Due to this, the potential for cross-contamination between batches becomes virtually impossible. This is a key benefit when considering the potential detrimental effects contamination of a pharmaceutical product can have.
Reduced Energy & Water Consumption
The switch to single-use systems from traditional technologies results in a reduction in energy and water consumption. It has been estimated that 30,000 litres of water are required to support the production of 1kg of a recombinant biopharmaceutical produced in a microbial system, with the use of traditional manufacturing technologies[1]. Biopharmaceutical manufacturing facilities can see a reduction in energy and water consumption of up to 46% when utilising single-use technologies over stainless steel bioreactors. Facilities utilising single-use technologies also have a 35% lower CO2 footprint than those which use stainless-steel reactors [2].
Reduced Costs
Making the decision to switch from traditional technologies to single-use systems can also result in significant cost-saving. In order to clean stainless steel systems, steam in place (SIP) must be implemented. The process is both expensive and labour-intensive, however if a single-use system is adopted this is eliminated. A survey conducted found that 72.9% of respondents have achieved cost savings by utilising single-use systems over other alternatives [3].
In terms of cost, functionality and productivity it is clear that adopting single-use systems in biopharmaceutical manufacturing facilities has many benefits. Due to this we should expect to see a change in the normal landscape of biopharmaceutical manufacturing facilities.
For more information on how Lennox can work with you, contact Calvin Malone at Calvin.Malone@lennox.ie.
[1] Walsh, G. (2013). Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition. Gary Walsh. John Wiley & Sons Ltd: ISBN 0 470 84326 8 (ppc), ISBN 0 470 84327 6 (pbk).
[2] Saxena, P. (2018). 6 Benefits of Single-Use Bioprocessing. Market Research Blog, Bioprocess International. https://blog.marketresearch.com/6-benefits-of-single-use-bioprocessing
[3] Caine, B. (2009). Presentation at the BPSA Membership Meeting. Hyatt Regency La Jolla. (publisher, BioProcess International). La Jolla, CA; 2 June 2009